MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII SHIELDED BLADED ACCESS SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFB73
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopy.Event description: information provided by the facility on (b)(6) 2025: part of this trocar fell in the abdominal cavity while performing gynecology laparoscopic case (clear plastic piece).It was just incidental that we noticed during the surgery that the plastic piece floating in the abdominal cavity.We have to open second trocar to confirm that it came from the kii 10mm trocar that is in the patient.Additional information provided by the facility on (b)(6) 2025: laparoscopic port.Observed plastic ring in the abdomen from the port inside the abdomen.Placed sponge down the trocar to clean out the port and must have dislodged at that time and been pushed into the abdomen.There was no clinical impact to the patient as a result of the event.Removed plastic ring from the abdomen.Curved kelly used to grasp sponge and put it down trocar to clean out the plastic internal ring.Intervention: removed plastic ring from the abdomen.Patient status: stable - unharmed.
Event or Problem Description
Procedure performed: laparoscopy.Event description: information provided by the facility on (b)(6) 2025: part of this trocar fell in the abdominal cavity while performing gynecology laparoscopic case (clear plastic piece).It was just incidental that we noticed during the surgery that the plastic piece floating in the abdominal cavity.We have to open second trocar to confirm that it came from the kii 10mm trocar that is in the patient.Additional information provided by the facility on 22jul2025: laparoscopic port.Observed plastic ring in the abdomen from the port inside the abdomen.Placed sponge down the trocar to clean out the port and must have dislodged at that time and been pushed into the abdomen.There was no clinical impact to the patient as a result of the event.Removed plastic ring from the abdomen.Curved kelly used to grasp sponge and put it down trocar to clean out the plastic internal ring.Additional information provided by facility on 05aug2025: yes, pieces fell into the patient.It was disassembled to match up with a second one that was used as a reference, making sure that all the pieces was retrieved from the at that time.Yes, instrumentation passed through the event unit during the procedure.It was disassembled to match up with a second one that was used as a reference, making sure that all pieces were retrieved from the at the time.The piece that fell into the patient's abdominal cavity is an internal part that you will find inside the seal housing.A unraveled raytec and curved kelly passed through the port.Intervention: removed plastic ring from the abdomen.Patient status: stable - unharmed.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainant¿s experience of shield dislodgement.Based on the description of the event, it is likely that the dislodged shield, an internal plastic component, was caused by an asymmetrical instrument that was inserted in a non-axial manner.Applied medical¿s instructions for use (ifu) states that, ¿extra care should be used when inserting angular and asymmetrical instruments, such as ¿j¿ hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing¿.Applied medical has performed a historical trend analysis and review of production records, and no relevant documentation was identified.
Event or Problem Description
Procedure performed: laparoscopy.Event description: information provided by the facility on 17jul2025: part of this trocar fell in the abdominal cavity while performing gynecology laparoscopic case (clear plastic piece).It was just incidental that we noticed during the surgery that the plastic piece floating in the abdominal cavity.We have to open second trocar to confirm that it came from the kii 10mm trocar that is in the patient.Additional information provided by the facility on 22jul2025: laparoscopic port.Observed plastic ring in the abdomen from the port inside the abdomen.Placed sponge down the trocar to clean out the port and must have dislodged at that time and been pushed into the abdomen.There was no clinical impact to the patient as a result of the event.Removed plastic ring from the abdomen.Curved kelly used to grasp sponge and put it down trocar to clean out the plastic internal ring.Additional information provided by facility on 05aug2025: yes pieces fell into the patient.It was disassembled to match up with a second one that was used as a reference, making sure that all the pieces was retrieved from the at that time.Yes instrumentation passed through the event unit during the procedure.It was disassembled to match up with a second one that was used as a reference, making sure that all pieces were retrieved from the at the time.The piece that fell into the patient's abdominal cavity is an internal part that you will find inside the seal housing.A unraveled raytec and curved kelly passed through the port.Intervention: removed plastic ring from the abdomen.Patient status: stable - unharmed.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a black component and clear component.Visual inspection confirmed the complainant¿s experience of seal component fragmentation and dislodgment.Based on the condition of the returned unit and description of the event, it is likely the reported event was caused by an asymmetrical instrument that was inserted through the trocar in a non-axial manner.Applied medical¿s instructions for use (ifu) states that, ¿extra care should be used when inserting angular and asymmetrical instruments, such as ¿j¿ hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.¿ applied medical has performed a historical trend analysis and review of production records, and no relevant documentations were identified.

• Brand Name: KII SHIELDED BLADED ACCESS SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 22681776
• Report Number: 2027111-2025-00666
• Device Sequence Number: 21223921
• Product Code: GCJ
• UDI-Device Identifier: 00607915117634
• UDI-Public: (01)00607915117634
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CFB73
• Device Catalogue Number: 101478481
• Device Lot Number: 1535212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/15/2025; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: KELLY, SPONGE
• Patient Sex: Unknown